Relax [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2015-08-10 20:33 (3620 d 19:45 ago) – Posting: # 15214
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Hi Balaga,

❝ Please respond any one,


Such an “ASAP” attitude sends me into a deep slumber. We are posting in our free time here…

❝ Whether the the person who involved in the clinical phase of the study is able to involve in the bioanalytical phase also? If so, then what about the compliance to the treatment blinding condition?


Can you give an example? A study nurse doing liquid-liquid extraction?

One of my stories. We had to deal with a very sensitive drug and stabilization was a tricky pro­­cedure. We decided not to leave it on the shoulders of the clinical staff but opted for one of our bioanalysts. To avoid troubles with breaking the blind, we also decided that this analyst was not part of the team working in the analytical phase later on. But: You never can proof to an inspector that this guy is not an idiot savant who easily memorizes a three page random list and tell it to his colleagues later. :-D

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